ARRAY 797-301

A phase 3, multinational, randomized, placebo-controlled study of ARRY-371797 in patients with symptomatic dilated cardiomyopathy due to a lamin A/C gene mutation.

Type: Drug trial

Principal Investigator: Saurabh Kapoor, MD

Trial is open for enrollment

• Newark Beth Israel Medical Center

HeartMate 3/ MOMENTUM 3

A multicenter study of MagLev technology in patients undergoing MCS therapy with HeartMate 3.

Type: Device trial

Principal Investigator: Margarita Camacho, MD

Trial is not open for enrollment

• Newark Beth Israel Medical Center

GALACTIC-HF

A multicenter, double-blind, randomized, placebo-controlled study to assess the efficacy and safety of omecamtiv mecarbil on mortality and morbidity in subjects with chronic heart failure with reduced ejection fraction.

Type: Drug trial

Principal Investigator: Mark J. Zucker, MD, JD

Trial is not open for enrollment

• Newark Beth Israel Medical Center

HeartMate PHP SHIELD II

A multicenter, prospective, randomized, open-label trial indicated for use during high-risk percutaneous coronary interventions (PCI) performed in elective or urgent, hemodynamically stable patients with severe coronary artery disease and depressed left ventricular ejection fraction.

Type: Device trial

Principal Investigator: Marc Cohen, MD

Trial is not open for enrollment

• Newark Beth Israel Medical Center

COMPASSION PAS

Evaluation of the longer-term safety and effectiveness of the SAPIEN XT transcatheter heart valve (THV) in the pulmonic position for the intended patient population (especially pediatric) when used as indicated with all valve sizes.

Type: Device trial

Principal Investigator: Marc Cohen, MD and Rajiv Verma, MD

Trial is open for enrollment

• Newark Beth Israel Medical Center

Partner 2

Evaluation of the safety and effectiveness of the SAPIEN 3 transcatheter heart valve (THV) with associated delivery systems in intermediate patients with severe symptomatic aortic stenosis.

Type: Device trial

Principal Investigator: Sergio Waxman, MD

Trial is not open for enrollment

• Newark Beth Israel Medical Center

PORTICO

A multicenter, prospective, randomized, controlled clinical study designed to evaluate the safety and effectiveness of the Portico Transcatheter Heart Valve (THV) and delivery systems via transfemoral and alternative delivery methods.

Type: Device trial

Trial is open for enrollment

• Saint Barnabas Medical Center
• Newark Beth Israel Medical Center

AMULET

A multi-center, prospective, randomized active control worldwide trial, designed to evaluate the safety and effectiveness of the AMPLATZER™ Amulet™ left atrial appendage occluder.

Type: Device trial

Trial closed for enrollment

• Saint Barnabas Medical Center

PFO PAS

A multicenter, single arm study to confirm the safety and effectiveness of the AMPLATZER™ PFO Occlude in the postapproval setting.

Type: Device trial

Principal Investigator: Marc Cohen, MD

Trial is open for enrollment

• Saint Barnabas Medical Center
• Newark Beth Israel Medical Center

GUIDE-HF

Demonstrate the effectiveness of the CardioMEMS Heart Failure System in an expanded patient population, including heart failure patients outside of the present indication, but at risk for future heart failure (HF) events or mortality.

Type: Device trial

Principal Investigator: Donald Rubenstein, MD

Trial is open for enrollment

• Saint Barnabas Medical Center
• Newark Beth Israel Medical Center

SPYRAL HTN OFF MED

Assessment of the efficacy and safety of renal denervation in the absence of antihypertensive medications.

Type: Device trial

Principal Investigator: Sabino Torre, MD

Trial is open for enrollment

• Saint Barnabas Medical Center

EARLY TAVR

Evaluation of transcatheter aortic valve replacement (TAVR) compared to surveillance for patients with asymptomatic severe aortic stenosis.

Type: Device trial

Principal Investigator: Sergio Waxman, MD

Trial is open for enrollment

• Newark Beth Israel Medical Center